FDA DevicesClass II
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CA...
Published: May 20, 2026Recall ID: Z-2191-2026Category: devicesCountry: US
Reason for Recall / Hazard
Incomplete seals on sterile product
Product Description & Identification
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Additional Source Details
| Field | Value |
|---|---|
| City | Tempe |
| State | AZ |
| Event id | 98708 |
| Address 1 | 1810 W Drake Dr |
| Code info | UDI 00885825007263, Lot Numbers: 3016810, 4488621, 4592565, 4801485, 4882673, 4967856, 4993019, 5004980, 5043929, 5071232, 3481897, 4488631, 4592566, 4802770, 4882750, 4967857, 4993023, 5005187, 5043930, 5071390, 3625879, 4488632, 4592567, 4804079, 4882752, 4967858, 4993039, 5005189, 5043931, 5071391, 3839101, 4488634, 4592569, 4807663, 4882753, 4968857, 4993040, 5005332, 5043932, 5071455, 3957393, 4488637, 4592570, 4807753, 4882754, 4968859, 4993322, 5005666, 5043985, 5071456, 3969685, 4488639, 4592571, 4807830, 4882758, 4968860, 4993327, 5005943, 5043986, 5071458, 3969688, 4488714, 4593641, 4808039, 4883012, 4968861, 4993563, 5005944, 5043988, 5071963, 3969689, 4488715, 4593648, 4808040, 4883125, 4968862, 4993564, 5008502, 5043990, 5071964, 3969691, 4488739, 4593688, 4808043, 4883516, 4968863, 4993567, 5009554, 5044183, 5071999, 3997894, 4488740, 4593691, 4808044, 4883867, 4969223, 4993568, 5009555, 5044426, 5072263, 4033681, 4488741, 4600193, 4808744, 4883868, 4971027, 4993570, 501... [TRUNCATED] |
| Postal code | 85283-4327 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 1352 units |
| Reason for recall | Incomplete seals on sterile product |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260410 |
| Center classification date | 20260513 |
Overview
- Recalling FirmStryker Sustainability Solutions
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide and the countries of Israel and Canada.